Monday Roundup

Rx coverage

Monday Roundup

David Ermer–ACA, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Healthcare Dive reports that Utah-based “Intermountain Healthcare and South Dakota-based Sanford Health announced Monday that the two had signed a letter of intent to merge. Together the two will operate 70 hospitals — many of which will be located in rural communities across the country — and 435 clinics and insure 1.1 million people.” Intermountain participates in the FEHB under the name of its affiliate SelectHealth.

The Labor Department’s Employee Benefit Security Administration (“EBSA”) released its 2020 edition of its federal mental health and substance use disorder parity self compliance tool for health plans. The first edition was released in April 2018. What’s more on Thursday October 29 at 2 pm ET EBSA will hold a free compliance assistance webcast on this complicated law.

Here’s a link to OPM’s third quarter 2020 report on the development of its Master Enrollment Index for the FEHBP.

The Centers for Medicare and Medicaid Services posted information today about the ACA federal marketplace open enrollment period which begins on Saturday November 1 and ends on December 15, 2020.

Over the weekend, the FEHBlog read in the Wall Street Journal’s Numbers column about COVID-19 mortality predictions. The author explains that

Now, as many as 50 different research groups make predictions, but one of the most accurate assembles all of the individual models, calculates the median value and looks no more than four weeks into the future.

The ensemble forecast was founded by the Reich Lab at the University of Massachusetts, Amherst, in collaboration with the Centers for Disease Control and Prevention and is based in part on models previously developed to forecast influenza and other infectious diseases.

In the next four weeks, it predicts the total number of deaths attributed to the new coronavirus will surpass 240,000—adding roughly 17,000 deaths to the current tally.

Such projections help policy makers and health-care officials decide how to manage resources and implement or relax interventions intended to curb the spread of the disease.

On the brighter side —

  • The Wall Street Journal reports that

A Covid-19 vaccine being developed by the University of Oxford and AstraZeneca AZN 2.06% PLC showed a promising immune response and low levels of adverse reactions in the elderly and older adults, according to an interim analysis that the drugmaker said was encouraging.

The vaccine, now in late-stage human trials aimed at showing its efficacy and safety, is a front-runner in the global sprint for a shot to protect lives and jump-start economies hobbled by the pandemic. Trials in the U.K. could produce results before year-end, fueling hopes among scientists and government leaders that a vaccine might be available for high-risk groups here by early 2021.

  • Fierce Healthcare informs us that “CVS views its pharmacists as playing a key role in assuaging fears, CEO Larry Merlo said Friday. Merlo, speaking at an event hosted by The Washington Post, said that pharmacists “are among the most trusted professionals” in the industry and as such will be able to educate patients about the safety and efficacy of the vaccine.”
  • Fierce Healthcare also recognizes “ten women who have risen to the challenges posed by COVID, as well as played a role in positioning their respective companies to be where they are today.” For example, Anthem Blue Cross’ Liz Kwo M.D. is scaling digital products to improve outcomes. Bravo to all of the winners.

Friday Stats and More

David Ermer–COVID-19, HIPAA Privacy and Security Rules, Rx coverage, U.S. Healthcare, Uncategorized–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 38th weeks of this year (beginning May 14 and ending September 23; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

For context take a look at this USA Today article on the three leading causes of death in the United States over the past 85 years (ending in 2018). COVID-19 will be taking over at least the spot for the third leading cause of death, which is currently held by accidental injuries.

In other news —

  • Forbes offers an update on Rite-Aid pharmacies and its prescription benefit manager. “Rite Aid said it will fully transition the PBM to Elixir in December and is “committed to becoming a dominant mid-market PBM, Rite Aid chief executive office Heyward Donigan said Thursday on the company’s second quarter earnings call.”
  • Benefits Pro (registration required) discusses the critical importance of educating employees about the advantages of health savings accounts. “Employers and financial advisors should discuss HSAs in the context of emergency savings and retirement planning, not just health care elections during annual enrollment.” The FEHBlog misses his ability to contribute to an HSA, an ability that he lost when he became Medicare eligible last year.
  • The Federal Times notes that Congress appears to be successfully convincing the Trump Administration to allow affected federal employees to opt out of the currently mandatory payroll tax deferral program. The article erroneously states that “The private sector does have the choice of whether to opt into the program, but feds and military members were automatically included.” Just like in the federal sector, it is the employer who makes the primary decision to participate in the payroll deferral program. It’s also the employer’s choice to allow employees to opt out of payroll deferral.
  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules took a big scalp today. “Premera Blue Cross (PBC) has agreed to pay $6.85 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 10.4 million people. This resolution represents the second-largest payment to resolve a HIPAA investigation in OCR history. PBC operates in Washington and Alaska, and is the largest health plan in the Pacific Northwest, serving more than two million people.” The breach dates from the bad old days of 2014-15 when Anthem and OPM announced massive data breaches due to cyberattacker gaining deep access to company information systems.
  • ZDnet reports on recent cyberattack on an unidentified federal agency system. It’s worth reading because

[While] The name of the hacked federal agency, the date of the intrusion, or any details about the intruder, such as an industry codename or state affiliation, were not disclosed, CISA officially publish[ed] an in-depth incident response (IR) report detailing the intruder’s every step. The report, which ZDNet analyzed today, reveals how the intruder gained access to the federal agency’s internal networks through different channels, such as leveraging compromised credentials for Microsoft Office 365 (O365) accounts, domain administrator accounts, and credentials for the agency’s Pulse Secure VPN server.

Midweek Update

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Manasvita S on Unsplash

Roll Call informs us that the House of Representatives pass the compromise Fiscal Year 2021 continuing resolution (H.R. 8337) by a wide margin. The bill heads onto the Senate which is expected also to pass the bill before the end of the current fiscal year next Wednesday September 30.

In COVID-19 news —

Johnson & Johnson (J&J) has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. * * * Unlike its rivals, J&J is evaluating the safety and efficacy of a single dose of a COVID-19 vaccine. If the one-dose regimen is successful, J&J could eliminate the logistical complexity and dropouts associated with trying to get people to return for a second shot. A one-shot regimen would also enable J&J to vaccinate 1 billion people each year. Few manufacturers of two-dose regimens can match that figure. * * *

In disclosing the start of the phase 3, J&J also called out the storage requirements of its vaccine. The candidate is expected to be stable for two years at -20°C and for upward of three months in the 2°C to 8°C range used to store many biologics. J&J said the candidate is “compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Pfizer’s mRNA vaccine must be kept at -70⁰C and be used within 24 hours of being thawed. Other COVID-19 vaccines have storage requirements more comparable to those of J&J’s shot.

Good news.

  • Fierce Healthcare reports that Walmart plans to use drones to deliver self-administered COVID-19 tests to single family homes within a one miles radius of one of their “pilot” stores. The recipient will need to mail the nasal sample to a lab. The gold standard will be self administered tests that can read out at home like a pregnancy test, but they are getting closer.

Fierce Healthcare also calls our attention to the fact that Optum’s latest quarterly drug pipeline report explains how health plans can prepare to cover “chimeric antigen receptor T-cell (CAR-T) therapies coming to market. CAR-T treatments for cancer are costly but are proliferating as they offer a potentially curative treatment for the disease. Through CAR-T therapy, a patient’s cells are modified in a lab and then reintroduced to the body to attack the cancer.”

The Health and Human Services Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, took another HIPAA business associate scalp today.

CHSPSC LLC, (“CHSPSC”) has agreed to pay $2,300,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over six million people. CHSPSC provides a variety of business associate services, including IT and health information management, to hospitals and physician clinics indirectly owned by Community Health Systems, Inc., in Franklin, Tennessee.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Becker’s Health IT offers 20 bold health IT predictions for the next five years. Here are the FEHBlog’s favorites:

1. Joel Klein, MD. Senior Vice President and CIO of University of Maryland Medical System (Baltimore): I think at least half of all healthcare in America will be virtual within five years. There are two barriers:

• Payers. They might pay less but if they pay enough, it will be enough. If we can figure out how to solve emergency department visits with widespread, cost effective on-demand care, that will make a difference.
• ‘But I want to see my doctor.’ That might be true for some things, but the convenience factor (especially for tertiary care… especially for millennials…) once you really start doing it overwhelms most of the physical presence upsides.

Edward Lee, MD. CIO of The Permanente Federation (Oakland, Calif.): In five years, physicians will no longer need to manually document their notes into the EHR. Instead, artificial intelligence will capture all the pertinent information from the patient-physician encounter. This will enable physicians to spend quality time with their patients instead of worrying about writing their notes or placing orders in a computer system. Joy and meaning for physicians will increase, physician burnout will decrease, and above all, patient care will improve.

Michael Pfeffer, MD. Assistant Vice Chancellor and CIO of UCLA Health: Health IT will enable each patient to have a unified, interactive view of their health information regardless of place of care or type of clinical data (i.e. phenotypic, genomic, imaging). AI-based apps will help make sense of their data, taking into account social determinants of health and potential health disparities to improve health equity and health literacy. This intelligence will be paired with personal health preferences and data on health provider quality, access, pricing and satisfaction to help patients make truly informed decisions about their care.

Fierce Biotech reports that “Just under a week after it stopped its key phase 3 pandemic vaccine test [due to a safety concern], AstraZeneca and the University of Oxford have been given the green light to restart in the U.K.” What’s more

While AZ and Oxford have been highlighted as [COVID-19 vaccine] race leaders, so too have Pfizer and BioNTech, which said they now want to boost their phase 2/3 trial for one of their five mRNA vaccines, BNT162b2, from around 30,000 to 44,000.

Also over the weekend, the companies said they have asked the FDA for the extra participants in order to include a broader patient population and with plans to include adolescents as young as 16 and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C or hepatitis B infection to “provide additional safety and efficacy data.”

It said it’s on track to hit its original target of 30,000 patients this week; despite wanting more people, Pfizer said in a statement that it was still on course to deliver data by the end of next month.

CVS Health announced last week that in response to demand created by children returning to school, it has made “children age 12 years and older eligible for testing at the more than 2,000 test sites located at select CVS Pharmacy drive-thru testing locations, starting last Friday, September 11.”

In other news

  • The Washington Post reports that commuting in the Washington DC metropolitan area may not be back to normal until next summer.

Some 430 employers representing about 275,000 workers in the greater-Washington region — stretching from Baltimore to Richmond — participated in the survey conducted Aug. 10 to 28. Their responses offer a snapshot of what companies are thinking as they weigh resuming in-office operations.
A clear majority of Washington-area employers said they are adopting a phased approach to returning to the office, although many said they remain uncertain about the timing of that return. A third of the region’s employers said they don’t know whether they will have their workers back on site by next summer.

  • Govexec.com reports that “The Office of Personnel Management issued a proposed rule [today] that would enable federal agencies to appoint employees in STEM jobs, or positions on temporary or new projects or organizations, for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects and other non-permanent work. Current regulations require agencies to get special permission from OPM to keep any term employee on staff for longer than four years.” The public comment deadline is November 10, 2020.
  • The House Oversight and Reform subcommittee on government operations held a postal update hearing today. It turns out that the subcommittee’s objective was to be to call the Postmaster General’s qualifications into question. A bipartisan Postal Service Board of Governors selects the Postmaster General, rather than following the usual Presidential appointment followed by Senate confirmation route.

Midweek update

David Ermer–ACA, COVID-19, Medicare, Rx coverage, U.S. Healthcare–

Section 1557 is the individual non-discrimination provision of the Affordable Care Act. In June 2020, the Department of Health and Human Services issued a final rule making numerous changes to the Obama Administration’s rule. Both rule makings sparked lawsuits challenging their legality.

Last time around, the lead case, Franciscan Alliance v. HHS, was filed in the Northern District of Texas. That case is still pending on appeal before the U.S. Court of Appeals for the Fifth Circuit.

This time around, the lead case, Whitman-Walker Clinic v. HHS, was filed in Washington, D.C. Roughly one month following oral argument in the case, U.S. District Judge James Boasberg this afternoon denied the plaintiffs’ motion for a preliminary injunction against enforcement of HHS’s revised Section 1557 rule with two exceptions:

  • The Court preliminarily enjoined the revised rule’s repeal of the sex discrimination definition found in the replaced Obama Administration rule. That definition afforded express protection to transgendered people.
  • The Court also preliminarily enjoined the revised rule’s religious organization exception to the law’s sex discrimination restrictions.

Here is a link to the lengthy yet illuminating opinion and the implementing order. The decision called to the FEHBlog’s attention another interesting civil rights provision of the ACA — Section 1554. This provision places limits on the HHS Secretary’s broad reaching regulatory powers under the ACA.

Judge Boasberg’s decision expands on the Brooklyn federal court decision issued August 17, 2020, that stayed enforcement of the sex discrimination definition repeal. While the federal government has not appealed the Brooklyn decision, the plaintiffs in the FEHBlog’s opinion are likely to appeal the denial of their preliminary injunction motion in the Whitman-Walker Clinic case. And so it goes.

The Centers for Medicare and Medicaid today released its final Medicare Part A inpatient prospective payment system rule for the government fiscal year beginning October 1, 2020.

The increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.9 percent. This reflects the projected hospital market basket update of 2.4 percent and a 0.0 percentage point productivity adjustment. This also reflects a +0.5 percentage point adjustment required by legislation.

Hospitals may be subject to other payment adjustments under the IPPS, including:

— Penalties for excess readmissions, which reflect an adjustment to a hospital’s performance relative to other hospitals with a similar proportion of patients who are dually eligible for Medicare and full-benefit Medicaid
— Penalty (1 percent) for worst-performing quartile under the Hospital-Acquired Condition Reduction Program
— Upward and downward adjustments under the Hospital Value-Based Purchasing Program

Medicare is one complicated program. Medicare is relevant to the FEHBP because the program impact the prices that FEHB plans pay for patient care and there is a large cadre of annuitant enrollees with Medicare Part A coverage.

In other healthcare related news —

  • Reuters reports that “President Donald Trump said on Tuesday he planned to meet with pharmaceutical companies this week regarding his so-called most- favored-nation executive order aimed at lowering drug prices paid by the U.S. federal government.”
  • STAT News reports that

A new analysis of several studies in which [inexpensive] steroid drugs were used to treat severely ill Covid-19 patients found the drugs significantly helped reduce patient deaths, bolstering earlier, preliminary evidence for the benefit of these medications. In multiple studies involving a total of 1,700 patients, a number of corticosteroids—anti-inflammatory drugs that can damp the effects of an overactive immune system—helped reduce deaths from Covid-19 by about a third, compared with patients who didn’t receive steroids, according to the analysis published Wednesday in the Journal of the American Medical Association.

  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, has created a consolidate website regarding HIPAA and Health Apps. The site includes links to generally helpful technical information on cloud computing and HIPAA and HIPAA and health IT. Check it out.

Monday Roundup

David Ermer–CDC, COVID-19, OPM, Rx coverage, Telehealth, U.S. Healthcare–

The Wall Street Journal provides a roundup on the status of the front runners in the race for a safe and effective COVID-19 vaccine. “Nine of these have advanced into Phase 3, which tests whether the dose that would be given to the public works safely.” The Phase 3 candidates fall into one of the following three vaccine approaches

Genetic-code vaccines deliver specific genetic instructions teaching the body’s cells to make a protein from the targeted virus, which in turn induces an immune response. One type incorporates a synthetic, engineered version of messenger RNA, or mRNA. These are molecules in the body that ferry DNA instructions for making immune-inducing proteins. Other gene-based vaccines use DNA itself.

A virus-based vaccine uses a killed or weakened form of the targeted virus to induce an immune response.

Viral vector vaccines use a modified virus different from the targeted virus to serve as a carrier of the vaccine teaching the body’s cells to make a protein from the targeted virus.

Candidates at the Phase 2 trial level are also using a protein-based approach that “incorporates a protein from the virus, or something resembling it, that will trigger an immune response.” The more, the merrier, right?

With respect to other COVID-19 ramifications:

  • Healthcare Dive discusses CDC surveys on the estimated 40% of Americans experienced a reduction in access to healthcare during the great hunkering down while Fierce Healthcare discusses how hospital systems are reacting to the drop.
  • The Healthcare Dive article also points out a “”separate CDC RANDS survey found that nearly 37% of people said their provider now offers a form of telehealth, compared to about 14% who said it was offered before the pandemic” while Health Payer Intelligence discusses what it takes to for health plans to build upon the uptick in virtual care.

In other healthcare news:

  • Fierce Healthcare reports on a new Aetna plan design for mid-sized and large employers in the Kansas City metropolitan area. “While the PPO plan will offer access to many regional providers, CVS’ HealthHubs and MinuteClinics are deeply embedded in the plan design, Aetna said.”
  • The Health Care Cost Institute released a study of its voluminous health plan claims data finding that “commercial [health plan] prices paid for the average professional service were 122% of what would have been paid under the Medicare Physician-Fee-Schedule.” The report looks at this comparison from several different angles.
  • Drug Channel analyzes GoodRx’s decision to make public stock offering. GoodRx offers prescription drug savings to consumers.

In follow up news:

  • Federal News Network reports on another National Finance Center announcement hitting the brakes on its earlier announced plan to implement the President’s August 8 executive order permitting employers to defer payroll taxes for certain employees as early as the first paycheck in September.
  • A Delaware Chancery Court judge, according to Fierce Healthcare, has decided that neither Anthem nor Cigna should receive damages as a result of the 2017 breakup of their planned merger. Hopefully that’s the end of this saga.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, Rx coverage, SCOTUS, Telehealth–

The FEHBlog noted in the latest Weekend Update that the President had allowed pharmaceutical manufacturers until August 24 to present alternative to the President’s plan to tie American drug pricing to foreign benchmarks via executive order. As of August 22, the President was waiting for such a proposal. and according to STAT News today —

The pharmaceutical industry is weighing two drug pricing policies that it could offer as a trade to President Trump, in exchange for his dropping a different proposal that drug makers detest, according to three drug industry lobbyists and a summary of the potential changes obtained by STAT.

In the meantime, the White House has not taken any action to implement this executive order.

On the COVID-19 front —

  • The Boston Globe reports that “An international meeting of Biogen leaders at a Boston hotel in February led to roughly 20,000 cases of COVID-19 in four Massachusetts counties by early May, far more than the 99 previously identified, according to three scientists involved in a new study.” Wow. That was a super spreader event for sure.
  • STAT News discusses “four scenarios on how we might develop immunity to Covid-19.” Interesting read.

Also other news from New England, Healthcare Dive informs us that

Google is investing $100 million in “Amwell, one of the biggest telehealth companies in the country, in a concurrent private placement with Amwell’s initial public offering, the two companies announced Monday. As part of the multiyear partnership, Amwell will become Google Cloud’s preferred telehealth platform and Amwell will migrate its video capabilities over to Google Cloud.”

Amwell is headquartered in Boston, Massachusetts.

Via AHRQ.gov, the FEHBlog ran across this recent study of “National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2017.” Here are the highlights:

In 2017, aggregate hospital costs for 35.8 million hospital stays totaled $434.2 billion.

The five most expensive inpatient conditions were septicemia, osteoarthritis, liveborn (newborn) infants, acute myocardial infarction, and heart failure. The 20 most expensive conditions accounted for slightly less than half of aggregate hospital costs.

The share of aggregate inpatient hospital costs by primary expected payer was 66 percent for Medicare and Medicaid combined, 27 percent for private insurance, and 3 percent for self-pay/no charge stays.

Septicemia ranked among the three most costly conditions in the hospital for all four expected payer groups

Conditions related to pregnancy and childbirth accounted for 4 of the top 20 most expensive conditions expected to be paid by Medicaid.

Medicaid was the only expected payer for which 3 of the top 20 most expensive conditions were related to mental and substance use disorders.

Finally, yesterday, the U.S. Supreme Court allocated oral argument time in Texas v. California case (No. 19-840) which raises the constitutionality of the Affordable Care Act for the third time before the Court.

The motions of the Solicitor General for divided argument and of the U.S. House of Representatives for enlargement of time for oral argument and for divided argument are granted, and the time is allotted as follows: 30 minutes for California, et al., 10 minutes for the U.S. House of Representatives, 20 minutes for the Solicitor General, and 20 minutes for Texas, et al. The motion of Ohio and Montana for leave to participate in oral argument as amici curiae, for enlargement of time for oral argument, and for divided argument is denied.

Weekend update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–

Yesterday, the House passed H.R. 8015 by a 257-150 vote. This bill would require a roll back of certain management changes at the Postal Service and provide the Postal Services with a $25 billion grant. The New York Times reports that

Senator Mitch McConnell of Kentucky, the majority leader, said plainly on Saturday that he did not plan to bring up a stand-alone bill in the Senate when lawmakers are at a stalemate over broader coronavirus relief legislation.

“The facts show the U.S.P.S. is equipped to handle this election, and if a real need arises, Congress will meet it,” he said in a statement. “The Senate will absolutely not pass stand-alone legislation for the Postal Service while American families continue to go without more relief.”

We shall see whether this House action leads to further talks between the House leadership and the White House.

No legislative action is scheduled to occur in either House of Congress this coming week, but some committee activity is scheduled. For example, the Postmaster General, among others, will testify before the House Oversight and Reform Committee tomorrow morning at 10 a.m. ET.

Forbes reminds us that tomorrow is the deadline for the prescription drug industry to provide feedback to the White House on its most favored nation drug pricing order.

President Trump postponed moving ahead with the executive order on drug pricing until Monday, August 24th, giving time to pharmaceutical manufacturers to come up with an alternative pricing proposal. In this respect, the executive order appears to be a one-month ultimatum to establish a bargaining position. If the Trump Administration isn’t satisfied with the alternative plan, it says it would push forward with the executive order. However, as of Saturday, August 22nd, drug makers have yet to offer an alternative pricing plan, and there’s no indication that the Trump Administration will reveal precise details of the executive order, let alone implement it in the next 48 hours. If the Trump Administration were to go ahead with, say, the IPI pilot program, it would likely face strong legal challenges.

Let’s face it in order to maintain the decreasing number of COVID-19 cases pending Food and Drug Administration (“FDA”) approval of a COVID-19 vaccine, we need (1) to maintain public health protections like social distancing, mask wearing, and avoiding super spreader events, (2) to be able to practically use a reliable, inexpensive COVID-19 test like the Yale saliva test, and (3)trust in medical researchers to bring more COVID-19 treatments on line.

With regard to the third point

Covid-19 clinical trials are now under way for 10 new monoclonal antibodies, known as mAbs in industry jargon, according to the Antibody Society, a professional association of researchers.

The most advanced are already in mid- and late-stage studies in newly diagnosed as well as hospitalized patients, and in people who haven’t yet been infected. If they clear testing, the drugs might be available as soon as early in the fourth quarter, according to Geoffrey Porges, an SVB Leerink LLC analyst.

In August, late-stage studies were launched evaluating Lilly’s lead antibody in hospitalized and nonhospitalized patients, and these could be completed before the end of the year, depending on how quickly patients are enrolled.

Regeneron expects to have the first data from its study of a monoclonal antibody in hospitalized and nonhospitalized patients by the end of September. The company could seek an emergency authorization based on the data if there is a strong indication the drug is blocking the virus.

  • The Wall Street Journal also reports this evening that that FDA ultimately gave emergency use authorization to convalescent plasma therapy treatment for hospitalized patients from COVID-19. This therapy also relies on antibodies. “For Covid-19 patients and the doctors who treat them, the designation opens up the possibility for faster and easier access to a promising treatment, while studies and clinical trials continue to explore who is helped and how much.”
  • Two former FDA commissioners, Doctors Scott Gottlieb and Mark McClellan offered an opinion piece published in the Wall Street Journal. They observe that

The development of drugs to treat Covid-19 is moving at a remarkable pace. The use of steroids is a major advance that is reducing the risk of death in hospitalized patients. Novel drugs, including manufactured antibodies that mimic the body’s immune response to the virus [referring to the monoclonal antibodies], are in late-stage development and could be available by the fall. There are about 750 drugs in screening studies (Phase II) or in large, definitive clinical trials (Phase III).

The challenge is to develop evidence as quickly as possible without compromising standards. Anytime there’s an unmet medical need, the tendency is to blame the Food and Drug Administration’s regulatory process. But if we don’t know what works, and what doesn’t, we’ll waste time and money on treatments that won’t help and may harm. Even if a vaccine is discovered and approved, the pandemic won’t end unless most Americans get vaccinated, which will require confidence in the product’s safety and efficacy.

Heartily agreed.

The FEHBlog ran across this interesting Health Payer Intelligence story about how Blue Cross and Blue Shield of Kansas City has created a social needs referral network.

The social needs referral network is a collection of community-based organizations that have partnered with Blue KC and that target social determinants of health needs in the Kansas City area. When Blue KC employees and provider partners come across a patient with a social determinants of health barrier, they can refer patients to these organizations.

In the spring of 2020, Blue KC launched an electronic platform to unify organization efforts, streamline social determinants of health screening data, and help Blue KC employees and provider partners more easily identify nearby community-based organizations that can meet particular patient needs.

Creative move.

Thursday Miscellany

David Ermer–CDC, COVID-19, Electronic health records, Rx coverage–

The Wall Street Journal reports that “Around the country, medical centers have begun setting up clinics focused on evaluating and treating Covid-19 patients reporting symptoms that last weeks or months after their initial illness or diagnosis. But the clinics are relatively new and hospitals are still adding resources, so wait lists can stretch months at the ones that exist so far.”

Healthcare Dive informs us that

Rideshare giant Uber is entering the prescription drug delivery business through a new partnership with on-demand prescription platform NimbleRx, the two companies announced Thursday. The partnership is currently live in Seattle and Dallas, with plans to expand to other parts of the country in the coming months, per a release. Nimble and Uber have completed more than 15,000 deliveries since the pilot launched earlier this summer.

Digital delivery marketplace Nimble, based in Redwood City, Calif., is used by more than 700 pharmacies in 34 states, giving the new partnership significant room to scale. Through an integration with Uber Direct, Uber’s delivery platform, the rideshare behemoth’s fleet of drivers will now be another delivery option for consumers.

It’s a crowded space: Retail pharmacy giants CVS Health and Walgreens have invested heavily in prescription home delivery following Amazon’s acquisition of online pharmacy Pillpack two years ago. Established players and startups alike are vying for a cut of runaway drug spending, while pitching better medication maintenance

CVS Health / Caremark and Express Scripts, among other PBMs, offer programs to allow health plan members to receive mail order pharmacy pricing on 90 day maintenance prescriptions at the pharmacy.

The Centers for Disease Control today released “Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2020–21 Influenza Season.”

Routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications continues to be recommended. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended, and appropriate product is available.

Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that vaccine-induced immunity might wane over the course of a season, vaccination is recommended to be offered by the end of October [2020].

Efforts should be structured to optimize vaccination coverage before influenza activity in the community begins. Vaccination should continue to be offered as long as influenza viruses are circulating and unexpired vaccine is available.

In the same vein, the Department of Health and Human Services (“HHS”) announced yesterday the issuance of a “third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to lifesaving childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the United States return to daycare, preschool and school. ‘Today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,’ said HHS Secretary Alex Azar. The amendment authorizes State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his or her State board of pharmacy) to order and administer vaccines to individuals ages three through 18 years, subject to several requirements” described in the announcement. Pharmacies have become a convenient administration point for many vaccinations, such as the flu vaccine.

Health Payer Intelligence reminds us that “Although the interoperability rule will not be implemented until mid-2021, payers can be aware of what to expect regarding how this rule will change their processes, as outlined in a recent AHIP brief.” The rule generally applies to plans regulated by HHS. While FEHB plans are not subject to the rule, they can benefit from riding in the slip stream by benefitting from interoperability innovations, such as HL7’s FHIR API standard.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 testing, OPM, Rx coverage–

The FEHBlog generally writes his posts at home in the evening, and he has been noting when it has been raining in Bethesda as it has been quite a rainy summer. This evening features blue skies (although it did rain this morning.)

On the COVID-19 front, the Department of Health and Human Services announced today

combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 per month. SARS-CoV-2 is the virus that causes COVID-19. The investments in Aegis Sciences Corporation and in Sonic Healthcare USA will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher Scientific and increase staffing and infrastructure to allow the U.S. to perform an additional 1 million tests each week by early October.

The American Hospital Association, the American College of Surgeons, and other major provider organizations have updated their roadmap for performing essential surgeries during the COVID-19 emergency. This may be helpful to health plan utilization review units.

A Wall Street Journal op-ed piece points out that

More than 500 clinical trials are under way world-wide in the race to find an effective treatment for Covid-19. Everybody wants it; nobody has it—yet. But one of the most promising therapies for Covid-19 patients uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body.

In preliminary studies, these cells cut the death rate significantly, particularly in the sickest patients. With a powerful 1-2-3 punch, these cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue—a combination offered by no other drug. This type of regenerative medicine could be as revolutionary as Jonas Salk’s polio vaccine.

Here’s a link to a STAT News report on newly released information on a study of convalescent plasma to treat COVID-19. Something has to pay off soon, right?

In general prescription drug news, GoodRx lists the twenty most expensive medicines in the U.S. The list identifies the manufacturer assistance program associated with each drug.

In other healthcare news —

  • Becker’s Hospital Review reports that UnitedHealthcare is resuming its COVID-19 delay effort to stop sending paper benefit checks to network providers. UHC plans to rely entirely on electronic payments. Smart move.
  • The Affordable Care Act provided government funding to create new CO-OP health plans. The FEHBlog criticized the decision as unnecessary. At on point there were 23 CO-OP plans and OPM was enlisting them for their ACA create Multi-State Program (“MSP”). ThinkAdvisor informs us that the New Mexico Co-op plan is shutting down at the end of this year which will leave three Co-ops operating in Maine and the Midwest. The MSP similarly failed because it was over-complicated and unnecessary.